Acova

Argatroban is an anticoagulant (thrombin inhibitor) that helps prevent the formation of blood clots.

Argatroban is used to treat or prevent blood clots in people who have thrombocytopenia (low levels of platelets in the blood) caused by using heparin. Argatroban is sometimes used in people who are undergoing a procedure called angioplasty (to open blocked arteries).

Argatroban may also be used for purposes not listed in this medication guide.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Serious side effects have been reported with Acova. See the "Drug Precautions" section.

Common side effects of Acova include the following:

• Bleeding
• Shortness of breath
• Low blood pressure
• Fever
• Headache
• Nausea
• Vomiting
• Diarrhea

This is not a complete list of Acova side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Contraindications

Hypersensitivity

Active major bleeding

Cautions

Monitor therapy with aPTT

Hemorrhagic diathesis, conditions that increase hemorrhage risk (eg, severe hypertension, major surgery, GI ulceration); unexplained fall in hematocrit or blood pressure may indicate hemorrhage

Hepatic dysfunction

Patients with illnesses that reduce clearance may require dose reduction

Safety and efficacy of concomitant administration with thrombolytic agents not established

Discontinue parenteral anticoagulant therapy prior to initiating treatment

No adjustment recommended

When argatroban was administered as a continuous infusion of 2 mcg/kg/min prior to and during a 4-hour hemodialysis session, approximately 20% was cleared through dialysis.

A retrospective analysis and case reports indicate that patients with HIT and renal failure requiring renal replacement therapy and undergo hemodialysis or continuous venovenous hemofiltration, no dosing adjustment is necessary. However, careful monitoring of aPTT is suggested.

Activated partial thromboplastin time (aPTT) should be obtained 2 hours after the start of treatment and after each dosage adjustment. Dosing is usually titrated to maintain an aPTT of 1.5 to 3 times baseline, but not exceeding 100 seconds.

Following cessation of argatroban therapy in patients with normal renal and hepatic function, full reversal of anticoagulation occurs within 2 to 4 hours; however, in patients with hepatic dysfunction, full reversal of anticoagulation may require at least 6 hours to achieve.

In a case series, argatroban was successfully used to treat patients with HIT and an elevated aPTT due to antiphospholipid antibody syndrome. Since aPTT monitoring is of uncertain reliability in this patient population, an alternative means of monitoring argatroban, such as ecarin clotting time and thrombin inhibitor management testing, has been suggested.

Argatroban has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy. Argatroban should only be given during pregnancy when need has been clearly established.

There are no data on the excretion of argatroban into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Argatroban has been detected in breast milk in animal studies.